5 INDICATIONS Description: The Precision Spine RCS Anterior Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion. The Precision Spine RCS Anterior Buttress Plate System consists of plates and bone screws. The Precision Spine RCS Anterior Buttress Plate System is also intended to provide stabilization and augment development of a solid spinal fusion. The Precision Spine RCS Anterior Buttress Plate System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO The products are supplied clean and NON-STERILE. SINGLE USE ONLY Indications: The Precision Spine RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications. Contraindications: The Precision Spine RCS Anterior Buttress Plate System contraindications include, but are not limited to: 1. Loss of proper spinal curvature, correction, height, and/ or reduction 2. Infection 3. Nonunion or delayed union 4. Foreign body reaction to the implants 5. Hemorrhaging 6. Loss of neurological function, dural tear, pain, and/or discomfort 7. Bone graft fracture, vertebral body fracture or discontinued growth of fusion at, above and/or below the surgery level 8. Bending, loosening, fracture, disassembly, slippage and/or migration of the components 9. Pain or discomfort 10. Change in mental status 11. Bursitis 12. Bone loss and/or bone fracture due to stress shielding 13. Inability to resume normal daily activities 14. Revision surgery 15. Death Potential Adverse Affects: The following potential adverse affects associated with the procedure have been shown to occur with the use of similar spinal systems. All patients considered candidates for fusion should be informed concerning the pathogenesis of their spinal abnormality, the rationale for fusion with instrumentation, and the potential adverse affects. The following are potential adverse affects, but not limited to: 1. Loss of proper spinal curvature, correction, height, and/or reduction 2. Infection 3. Nonunion or delayed union 4. Foreign body reaction to the implants 5. Hemorrhaging 6. Loss of neurological function, dural tear, pain, and/or discomfort 7. Bone graft fracture, vertebral body fracture or discontinued growth of fusion at, above and/or below the surgery level 8. Bending, loosening, fracture, disassembly, slippage and/or migration of the components 9. Pain or discomfort 10. Change in mental status 11. Bursitis 12. Bone loss and/or bone fracture due to stress shielding 13. Inability to resume normal daily activities 14. Revision surgery 15. Death Precautions: The implantation of the Precision Spine RCS Anterior Buttress Plate System should be performed only be experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. The Precision Spine RCS Anterior Buttress Plate has not been evaluated for safety and compatibility in the MR environment. The Precision Spine RCS Anterior Buttress Plate has not been tested for heating or migrations in the MR environment. 4

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Lumbar Spine Fusion (1 of 5) i If you need this information in another language or medium (audio, large print, etc) please contact the Customer Care Team on 0800 374 208 email: customercare@ salisbury.nhs.uk.

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